Hot Topics * Connect and Interact * Expert Presenters

Join hundreds of your colleagues from across the food and drug law community at this must-attend annual event to hear directly from leading regulators, both within and outside FDA, explore different viewpoints, shape policy, and advance understanding.

  • Hear FDA’s 2017 strategic priorities directly from the Acting Commissioner, Chief Counsel, and leadership of FDA’s product Centers;
  • Informative and thought-provoking plenary sessions;
  • More than 30 breakout sessions covering the latest in legal, regulatory, compliance, policy, marketing, and economic issues;
  • Learn from more than 100 well-known leaders in the federal government, industry, private bar, patient and consumer advocacy groups, consulting organizations, and academia; and
  • A variety of opportunities to learn and network in both large and small groups.

Sessions Include

  • Policies and Politics – Opportunities and Challenges for a New Administration
  • 21st Century Cures Act: FDA Provisions and Implications
  • Top 10 Cases in Food and Drug Law
  • Networking Lunch with Facilitated Table Topic Discussions

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, Acting Commissioner of Food and Drugs, Food and Drug Administration (FDA)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
Nancy Myers, President, Catalyst Healthcare Consulting
William Shultz, Partner, Zukerman Spaeder LLP
Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

Drug Development: Legal Considerations, Challenges, and Solutions for Data Collaboration in the Pre-Competitive Setting
Moderated by Debra Hanna, Executive Director, Critical Path to TB Drug Regimens, Critical Path Institute

Laboratory Developed Tests: What Now?
Jeanne Ireland, Principal, Ireland Strategies LLC
Sheila Walcoff, Consultant, Goldbug Strategies LLC
Moderated by Nancy Stade, Partner, Sidley Austin LLP

Key Regulatory Issues in Biosimilars
Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Christine Simmon, Senior Vice President of Policy and Strategic Alliances, Association of Accessible Medicines and Executive Director, Biosimilars Council
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

New Food Ingredients: US and EU Requirements and Strategic Considerations
Nicole Coutrelis, Partner, Coutrelis & Associes
Dennis M. Keefe, Director, Office of Food Additive Safety, CFSAN, FDA
Cathy Weir, Adjunct Faculty Member, Institute for Food Laws and Regulations, Michigan State University
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNarama, PC

The Animal Drug Compounding Debate
Rachael G. Pontikes, Partner, Duane Morris LLP
Ted Sullivan, Partner, Quarles & Brady LLP
Moderated by Brian J. Malkin, Counsel, Arent Fox LLP

Tobacco Product Standards for Combustible Products: Nicotine and Beyond
Sudhanshu Patwardhan, Senior International Engagement Manager, Nicoventures Ltd.
Moderated by Jack Henningfield, Vice President, Research & Health Policy, Pinney Associates Inc.

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

Communicating Emerging Drug Therapies Prior to FDA Approval
Michelle Drodz, Deputy Vice President, Policy and Research, Pharmaceutical Research Manufacturers Association
Michael Labson, Partner, Covington & Burling LLP
Moderated by Soumi Saha, Assistant Director of Pharmacy & Regulatory Affairs, Academy of Managed Care Pharmacy

Digital Health Technologies: A New FDA Regulatory Paradigm
Moderated by Kim Tyrrell-Knott, Partner, Partner, Epstein, Becker & Green PC

Biologics Across the Globe: New Regulatory Challenges and Opportunities
Freddy Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc., and Member, FDLI Board of Directors
Adora Ndu, Senior Director of Regulatory Policy, BioMarin Pharmaceutical, Inc.
Moderated by Lance Shea, Partner, Baker & Hostetler

Food and Dietary Supplement Class Action Litigation in a World of Less Regulation
Maia Kats, Director of Litigation, Center for Science in the Public Interest
Moderated by Anthony Anscombe, Partner, Sedgwick LLP

Patient-Centric Perspectives: Models for Patient Engagement
Marc Boutin, Chief Executive Officer, National Health Council
Kathryn O’Callaghan, Supervisory Health Scientist, CDRH, FDA
Moderated by Jeffrey Gibbs, Director, Hyman Phelps & McNamara, PC, and Chair, FDLI Board of Directors

Criminal Prosecutions Under the Food, Drug & Cosmetic Act
George M. Karavetsos, DLA Piper LLP
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Member, FDLI Board of Directors

12:30–2:00 PM: Luncheon

FDLI Distinguished Service and Leadership Awards
Presented by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors and Amy Comstock Rick, President & CEO, FDLI

Award Recipients:
Edward Basile, Senior Partner (retired), King & Spalding
Theresa Mullin, Director, Office of Strategic Programs, CDER, FDA
Anthony Young, Partner, Kleinfeld, Kaplan & Becker, LLP

Keynote Speaker

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

Center for Drug Evaluation and Research (CDER)
Richard A. Moscicki, Deputy Director for Science Operations, CDER, Office of Medical Products and Tobacco, FDA
Peter Pitts, President, Center for Medicine in the Public Interest
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals
Cathy Burgess, Partner, Alston & Bird LLP
Moderated by Sheldon Bradshaw, Partner, King & Spalding LLP

Center for Devices and Radiological Health (CDRH)
Jeffrey Shuren, Director, CDRH, Office of Medical Products and Tobacco, FDA
Janet E. Trunzo, Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed
Moderated by Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic, and Member, FDLI Board of Directors

Center for Biologics Evaluation and Research (CBER)
Peter W. Marks, Director, CBER, Office of Medical Products and Tobacco, FDA
Dan Kracov, Partner, Arnold & Porter Kaye Scholer LLP, and Member, FDLI Board of Directors
Moderated by Neil DiSpirito, Of Counsel, Ballard Spahr LLP

Center for Food Safety and Applied Nutrition (CFSAN)
Susan T. Mayne, Director, CFSAN, Office of Foods and Veterinary Medicine, FDA
Rend Al-Mondhiry, Associate General Counsel, Council for Responsible Nutrition
John H. Fuson, Partner, Crowell & Moring LLP
Moderated by Mel Drozen, Keller and Heckman

Center for Veterinary Medicine (CVM)
Steven M. Solomon, Director, CVM, Office of Foods and Veterinary Medicine, FDA
David P. Jones, Legal Director, Merck Animal Health
Moderated by Jeannie M. Perron, Partner, Covington & Burling LLP

Center for Tobacco Products (CTP)
Mitchell R. Zeller, Director, CTP, Office of Medical Products and Tobacco, FDA
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville, and Volunteer, American Heart Association
Scott Ballin, Health Policy Analyst
Moderated by Stacy Erlich, Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

Legal Limits on Pharmacy Adherence and Discount Programs
Don L. Bell, SVP & General Counsel, NACDS
Moderated by J. Mason Weeda, Olsson Frank Weeda Terman Matz PC

Emerging Issues and Trends in Biologics Compliance and Enforcement
John McShane, VP Quality Compliance and Client Services, Validant
Mark Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Moderated by Michael Druckman, Partner, Hogan Lovells LLP

What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement
Moderated by Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP

Veterinary Products and FTC Enforcement
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Gary L. Yingling, Senior Counsel, Morgan, Lewis & Bockius LLP

Tobacco Harm Reduction: Opportunities and Regulatory Pathways to Achieve
Marc S. Firestone, Senior Vice President & General Counsel, Philip Morris International
Joe Murillo, Vice President Regulatory Affairs, Altria Client Services
James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Dean R. Cirotta, President & COO, EAS Consulting Group

4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Service to FDLI Award
Presented by Bob Rhoades, Vice President, Client Services, Valident and Member, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
Award Recipient: Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Pfizer Inc.

FDA Alumni Association Award Presentation
Presented by Nancy Myers, President, Catalyst Healthcare Consulting
Award Recipient: Margaret Hamburg, former FDA Commissioner

9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks

Retsef Levi, J. Spencer Standish Professor of Management, Professor of Operations, Management, Sloan School of Management, MIT
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health LLC
Moderated by Brooke Schumm, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC

11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

Challenges and Opportunities in Combination Medical Product Regulation
James A. Boiani, Partner, Epstein, Becker & Green PC

FDA’s Implementation of the 21st Century Cures Act
Wade Ackerman, Partner, Covington & Burling LLP
Julia Tierney, Senior Policy Advisor for Strategic Planning and Legislation, Office of Chief Counsel, FDA
Moderated by Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.

Regulation of Cannabis in FDA-Regulated Products
Emily Leongini, Associate, Arent Fox LLP

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP
Moderated by Linda Goldstein, Partner, Manatt, Phelps & Phillips, LLP

CTP’s Compliance and Enforcement Initiatives Post-Deeming
Ann Simoneau, Director, Office of Compliance and Enforcement, CTP, FDA
Moderated by Stacey Gagosian, Director, Government Affairs, Truth Initiative

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

FDA’s User Fee Program Reauthorization Update
Remy Brim, Minority Health Policy Office, Senate HELP Committee
Tiffany Guarascio, Legislative Director and Health Policy Adviser, Committee on Energy and Commerce, U.S. House of Representatives
John Stone, Senior Counsel, Committee on Energy and Commerce, U.S. House of Representatives
Moderated by Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts

Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
Matthew Barrett, Program Manager of Cybersecurity Framework, NIST
Zachary Rothstein, Associate Vice President, Technology & Regulatory Affairs, AdvaMed Suzanne Schwartz, Associate Director for Science, CDRH, FDA
Suzanne Schwartz, Associate Director for Science, CDRH, FDA
Moderated by Sonali Gunawardhana, Of Counsel, Wiley Rein LLP

Defending Your Product: Crisis Management, Recalls, and Strategy
Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Mark Mansour, Partner, Mayer Brown LLP

Economic Considerations for Biosimilar Litigation
Anne Marie Polak, Senior Director, Leavitt Partners, LLC
Richard Mortimer, Managing Principal, Analysis Group, Inc.
Moderated by Lynn Rzonca, Partner, Ballard Spahr LLP

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law

Laurie Beyranevand, Associate Professor of Law, Associate Director, Center for Agriculture and Food Systems, Vermont Law School
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by Lynn Tyler, Partner, Barnes & Thornburg LLP

4:30 PM: Conference Adjournment

 

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, Acting Commissioner of Food and Drugs, Food and Drug Administration (FDA)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
Nancy Myers, President, Catalyst Healthcare Consulting
William Shultz, Partner, Zukerman Spaeder LLP
Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

New Food Ingredients: US and EU Requirements and Strategic Considerations
Nicole Coutrelis, Partner, Coutrelis & Associes
Dennis M. Keefe, Director, Office of Food Additive Safety, CFSAN, FDA
Cathy Weir, Adjunct Faculty Member, Institute for Food Laws and Regulations, Michigan State University
Moderated by Ricardo Carvajal, Director, Hyman, Phelps & McNarama, PC

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

Food and Dietary Supplement Class Action Litigation in a World of Less Regulation
Maia Kats, Director of Litigation, Center for Science in the Public Interest
Moderated by Anthony Anscombe, Partner, Sedgwick LLP

Criminal Prosecutions Under the Food, Drug & Cosmetic Act
George M. Karavetsos, DLA Piper LLP
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Member, FDLI Board of Directors

12:30–2:00 PM: Luncheon

FDLI Distinguished Service and Leadership Awards
Presented by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors and Amy Comstock Rick, President & CEO, FDLI

Award Recipients:
Edward Basile, Senior Partner (retired), King & Spalding
Theresa Mullin, Director, Office of Strategic Programs, CDER, FDA
Anthony Young, Partner, Kleinfeld, Kaplan & Becker, LLP

Keynote Speaker

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

Center for Food Safety and Applied Nutrition (CFSAN)
Susan T. Mayne, Director, CFSAN, Office of Foods and Veterinary Medicine, FDA
Rend Al-Mondhiry, Associate General Counsel, Council for Responsible Nutrition
John H. Fuson, Partner, Crowell & Moring LLP
Moderated by Mel Drozen, Keller and Heckman

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement
Moderated by Daniel R. Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP

4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Service to FDLI Award
Presented by Bob Rhoades, Vice President, Client Services, Valident and Member, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
Award Recipient: Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Pfizer Inc.

FDA Alumni Association Award Presentation
Presented by Nancy Myers, President, Catalyst Healthcare Consulting
Award Recipient: Margaret Hamburg, former FDA Commissioner

9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks

Retsef Levi, J. Spencer Standish Professor of Management, Professor of Operations, Management, Sloan School of Management, MIT
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health LLC
Moderated by Brooke Schumm, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC

11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

Regulation of Cannabis in FDA-Regulated Products
Emily Leongini, Associate, Arent Fox LLP

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP
Moderated by Linda Goldstein, Partner, Manatt, Phelps & Phillips, LLP

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

Defending Your Product: Crisis Management, Recalls, and Strategy
Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Mark Mansour, Partner, Mayer Brown LLP

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law

Laurie Beyranevand, Associate Professor of Law, Associate Director, Center for Agriculture and Food Systems, Vermont Law School
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by Lynn Tyler, Partner, Barnes & Thornburg LLP

4:30 PM: Conference Adjournment

 

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, Acting Commissioner of Food and Drugs, Food and Drug Administration (FDA)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
Nancy Myers, President, Catalyst Healthcare Consulting
William Shultz, Partner, Zukerman Spaeder LLP
Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

Drug Development: Legal Considerations, Challenges, and Solutions for Data Collaboration in the Pre-Competitive Setting
Moderated by Debra Hanna, Executive Director, Critical Path to TB Drug Regimens, Critical Path Institute

Laboratory Developed Tests: What Now?
Jeanne Ireland, Principal, Ireland Strategies LLC
Sheila Walcoff, Consultant, Goldbug Strategies LLC
Moderated by Nancy Stade, Partner, Sidley Austin LLP

Key Regulatory Issues in Biosimilars
Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP
Christine Simmon, Senior Vice President of Policy and Strategic Alliances, Association of Accessible Medicines and Executive Director, Biosimilars Council
Moderated by John R. Manthei, Partner, Latham & Watkins LLP

The Animal Drug Compounding Debate
Rachael G. Pontikes, Partner, Duane Morris LLP
Ted Sullivan, Partner, Quarles & Brady LLP
Moderated by Brian J. Malkin, Counsel, Arent Fox LLP

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

Communicating Emerging Drug Therapies Prior to FDA Approval
Michelle Drodz, Deputy Vice President, Policy and Research, Pharmaceutical Research Manufacturers Association
Michael Labson, Partner, Covington & Burling LLP
Moderated by Soumi Saha, Assistant Director of Pharmacy & Regulatory Affairs, Academy of Managed Care Pharmacy

Digital Health Technologies: A New FDA Regulatory Paradigm
Moderated by Kim Tyrrell-Knott, Partner, Partner, Epstein, Becker & Green PC

Biologics Across the Globe: New Regulatory Challenges and Opportunities
Freddy Jimenez, Vice-President, Law and Compliance, Celldex Therapeutics, Inc., and Member, FDLI Board of Directors
Adora Ndu, Senior Director of Regulatory Policy, BioMarin Pharmaceutical, Inc.
Moderated by Lance Shea, Partner, Baker & Hostetler

Patient-Centric Perspectives: Models for Patient Engagement
Marc Boutin, Chief Executive Officer, National Health Council
Kathryn O’Callaghan, Supervisory Health Scientist, CDRH, FDA
Moderated by Jeffrey Gibbs, Director, Hyman Phelps & McNamara, PC, and Chair, FDLI Board of Directors

Criminal Prosecutions Under the Food, Drug & Cosmetic Act
George M. Karavetsos, DLA Piper LLP
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Member, FDLI Board of Directors

12:30–2:00 PM: Luncheon

FDLI Distinguished Service and Leadership Awards
Presented by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors and Amy Comstock Rick, President & CEO, FDLI

Award Recipients:
Edward Basile, Senior Partner (retired), King & Spalding
Theresa Mullin, Director, Office of Strategic Programs, CDER, FDA
Anthony Young, Partner, Kleinfeld, Kaplan & Becker, LLP

Keynote Speaker

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

Center for Drug Evaluation and Research (CDER)
Richard A. Moscicki, Deputy Director for Science Operations, CDER, Office of Medical Products and Tobacco, FDA
Peter Pitts, President, Center for Medicine in the Public Interest
Rachel Turow, Executive Counsel – Regulatory Law, TEVA Pharmaceuticals
Cathy Burgess, Partner, Alston & Bird LLP
Moderated by Sheldon Bradshaw, Partner, King & Spalding LLP

Center for Devices and Radiological Health (CDRH)
Jeffrey Shuren, Director, CDRH, Office of Medical Products and Tobacco, FDA
Janet E. Trunzo, Senior Executive Vice President, Technology & Regulatory Affairs, AdvaMed
Moderated by Sandra Cohen Kalter, Vice President and Chief Regulatory Counsel, Medtronic, and Member, FDLI Board of Directors

Center for Biologics Evaluation and Research (CBER)
Peter W. Marks, Director, CBER, Office of Medical Products and Tobacco, FDA
Dan Kracov, Partner, Arnold & Porter Kaye Scholer LLP, and Member, FDLI Board of Directors
Moderated by Neil DiSpirito, Of Counsel, Ballard Spahr LLP

Center for Veterinary Medicine (CVM)
Steven M. Solomon, Director, CVM, Office of Foods and Veterinary Medicine, FDA
David P. Jones, Legal Director, Merck Animal Health
Moderated by Jeannie M. Perron, Partner, Covington & Burling LLP

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

Legal Limits on Pharmacy Adherence and Discount Programs
Don L. Bell, SVP & General Counsel, NACDS
Moderated by J. Mason Weeda, Olsson Frank Weeda Terman Matz PC

Emerging Issues and Trends in Biologics Compliance and Enforcement
John McShane, VP Quality Compliance and Client Services, Validant
Mark Levy, Partner, Eckert Seamans Cherin & Mellott, LLC
Moderated by Michael Druckman, Partner, Hogan Lovells LLP

Veterinary Products and FTC Enforcement
Jesse J. Sevcik, Sr. Director, Global Government Affairs, Elanco Animal Health
Gary L. Yingling, Senior Counsel, Morgan, Lewis & Bockius LLP

4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Service to FDLI Award
Presented by Bob Rhoades, Vice President, Client Services, Valident and Member, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
Award Recipient: Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Pfizer Inc.

FDA Alumni Association Award Presentation
Presented by Nancy Myers, President, Catalyst Healthcare Consulting
Award Recipient: Margaret Hamburg, former FDA Commissioner

9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks

Retsef Levi, J. Spencer Standish Professor of Management, Professor of Operations, Management, Sloan School of Management, MIT
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health LLC
Moderated by Brooke Schumm, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC

11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

Challenges and Opportunities in Combination Medical Product Regulation
James A. Boiani, Partner, Epstein, Becker & Green PC

FDA’s Implementation of the 21st Century Cures Act
Wade Ackerman, Partner, Covington & Burling LLP
Julia Tierney, Senior Policy Advisor for Strategic Planning and Legislation, Office of Chief Counsel, FDA
Moderated by Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.

Regulation of Cannabis in FDA-Regulated Products
Emily Leongini, Associate, Arent Fox LLP

Editorial or Ad? FTC’s Native Advertising Guidelines and Challenges for the Food and Drug Industry
Richard Cleland, Assistant Director, Bureau of Consumer Protection, Division of Advertising Practices, FTC
Kristi L. Wolff, Partner, Kelley Drye & Warren LLP
Moderated by Linda Goldstein, Partner, Manatt, Phelps & Phillips, LLP

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

FDA’s User Fee Program Reauthorization Update
Remy Brim, Minority Health Policy Office, Senate HELP Committee
Tiffany Guarascio, Legislative Director and Health Policy Adviser, Committee on Energy and Commerce, U.S. House of Representatives
John Stone, Senior Counsel, Committee on Energy and Commerce, U.S. House of Representatives
Moderated by Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts

Changing Landscape of IoT: Medical Device Privacy and Cybersecurity
Matthew Barrett, Program Manager of Cybersecurity Framework, NIST
Zachary Rothstein, Associate Vice President, Technology & Regulatory Affairs, AdvaMed Suzanne Schwartz, Associate Director for Science, CDRH, FDA
Suzanne Schwartz, Associate Director for Science, CDRH, FDA
Moderated by Sonali Gunawardhana, Of Counsel, Wiley Rein LLP

Defending Your Product: Crisis Management, Recalls, and Strategy
Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Mark Mansour, Partner, Mayer Brown LLP

Economic Considerations for Biosimilar Litigation
Anne Marie Polak, Senior Director, Leavitt Partners, LLC
Richard Mortimer, Managing Principal, Analysis Group, Inc.
Moderated by Lynn Rzonca, Partner, Ballard Spahr LLP

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law

Laurie Beyranevand, Associate Professor of Law, Associate Director, Center for Agriculture and Food Systems, Vermont Law School
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by Lynn Tyler, Partner, Barnes & Thornburg LLP

4:30 PM: Conference Adjournment

 

Wednesday, May 3

5:30–7:00 PM: Out-of-Towners Reception: Location: JW Marriott Hotel

Thursday, May 4

7:30–8:30 AM: Registration and Breakfast
8:30–8:45 AM: Welcome

Amy Comstock Rick, President & CEO, FDLI
Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Team, Eli Lilly and Company and FDLI Annual Conference Planning Committee Co-Chair

8:45–9:15 AM: FDA Keynote Address

Stephen Ostroff, Acting Commissioner of Food and Drugs, Food and Drug Administration (FDA)
Introduced by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors

9:15–10:15 AM: Policies and Politics – Opportunities and Challenges for a New Administration

Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
Nancy Myers, President, Catalyst Healthcare Consulting
William Shultz, Partner, Zukerman Spaeder LLP
Moderated by Amy Comstock Rick, President & CEO, FDLI

10:15–10:45 AM: Coffee and Networking Break
10:45–11:30 AM: Breakout Sessions

 Tobacco Product Standards for Combustible Products: Nicotine and Beyond
Sudhanshu Patwardhan, Senior International Engagement Manager, Nicoventures Ltd.
Moderated by Jack Henningfield, Vice President, Research & Health Policy, Pinney Associates Inc.

11:30–11:45 AM: Transition
11:45 AM–12:30 PM: Breakout Sessions

 Criminal Prosecutions Under the Food, Drug & Cosmetic Act
George M. Karavetsos, DLA Piper LLP
Moderated by Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP, and Member, FDLI Board of Directors

12:30–2:00 PM: Luncheon

FDLI Distinguished Service and Leadership Awards
Presented by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC and FDLI Chair, Board of Directors and Amy Comstock Rick, President & CEO, FDLI

Award Recipients:
Edward Basile, Senior Partner (retired), King & Spalding
Theresa Mullin, Director, Office of Strategic Programs, CDER, FDA
Anthony Young, Partner, Kleinfeld, Kaplan & Becker, LLP

Keynote Speaker

2:00–2:15 PM: Transition
2:15–3:30 PM: Breakout Sessions: FDA Center Directors

 Center for Tobacco Products (CTP)
Mitchell R. Zeller, Director, CTP, Office of Medical Products and Tobacco, FDA
Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville, and Volunteer, American Heart Association
Scott Ballin, Health Policy Analyst
Moderated by Stacy Erlich, Partner, Kleinfeld, Kaplan & Becker, LLP and Member, FDLI Board of Directors

3:30–4:00 PM: Coffee and Networking Break
4:00–4:45 PM: Breakout Sessions

 Tobacco Harm Reduction: Opportunities and Regulatory Pathways to Achieve
Marc S. Firestone, Senior Vice President & General Counsel, Philip Morris International
Joe Murillo, Vice President Regulatory Affairs, Altria Client Services
James M. Solyst, Vice President, Federal Regulatory Affairs, Swedish Match North America
Moderated by Dean R. Cirotta, President & COO, EAS Consulting Group

4:45–5:00 PM: Transition
5:00–5:30 PM: Speaker: Elizabeth H. Dickinson, Chief Counsel, FDA
5:30–7:00 PM: Networking Reception

Friday, May 5

7:30–8:30 AM: Breakfast
7:30–8:30 AM: FDLI Committees and How to Get Engaged
8:45–9:30 AM: Welcome

Leslie T. Krasny, Partner, Keller and Heckman LLP and FDLI Annual Conference Planning Committee Co-Chair

Service to FDLI Award
Presented by Bob Rhoades, Vice President, Client Services, Valident and Member, FDLI Board of Directors and Amy Comstock Rick, President & CEO, FDLI
Award Recipient: Geoffrey M. Levitt, Senior Vice President and Associate General Counsel, Pfizer Inc.

FDA Alumni Association Award Presentation
Presented by Nancy Myers, President, Catalyst Healthcare Consulting
Award Recipient: Margaret Hamburg, former FDA Commissioner

9:30–10:00 AM: FDA’s Mutual Reliance Initiative and Global Harmonization

Dara Corrigan, Associate Commissioner for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, FDA

10:00–10:30 AM: Coffee and Networking Break
10:30–11:15 AM: Identifying and Prioritizing Global Supply Chain Management Risks

Retsef Levi, J. Spencer Standish Professor of Management, Professor of Operations, Management, Sloan School of Management, MIT
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf Health LLC
Moderated by Brooke Schumm, President and Principal, Daneker, McIntire, Schumm, Prince, Manning & Widmann, PC

11:15–11:30 AM: Transition
11:30 AM–12:15 PM: Breakout Sessions

 CTP’s Compliance and Enforcement Initiatives Post-Deeming
Ann Simoneau, Director, Office of Compliance and Enforcement, CTP, FDA
Moderated by Stacey Gagosian, Director, Government Affairs, Truth Initiative

12:15–12:30 PM: Transition
12:30–1:30 PM: Luncheon & Facilitated Table Topic Discussions
1:30–1:45 PM: Transition
1:45–2:30 PM: Breakout Sessions

 Defending Your Product: Crisis Management, Recalls, and Strategy
Meredith Olearchik, Vice President and Associate General Counsel – Intellectual Property, Marketing and Food Law, Campbell Soup Company
Moderated by Mark Mansour, Partner, Mayer Brown LLP

2:30–2:45 PM: Coffee and Networking Break
2:45–3:30 PM: Keynote Address
3:30–4:30 PM: Top 10 Cases in Food and Drug Law

Laurie Beyranevand, Associate Professor of Law, Associate Director, Center for Agriculture and Food Systems, Vermont Law School
William M. Janssen, Professor of Law, Charleston School of Law
Moderated by Lynn Tyler, Partner, Barnes & Thornburg LLP

4:30 PM: Conference Adjournment

 

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Make more of your conference experience by adding online access to the synced audio and speaker slides for the keynote and plenary sessions to your registration for just $99 for members or $199 for nonmembers. Select the “optional function” to take advantage of this offer. You will be notified how to access the video after the conference.

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  • Member manufacturers, suppliers and distributors with more than $1 billion in sales as well as member law firms get one complimentary registration as part of their annual membership dues.
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  • Organizational members are also eligible for a group registration discount. Pay for four attendees and the fifth is complimentary.

To take advantage of these opportunities, please contact the Membership Department. For other Annual Conference questions, please contact Customer Service.

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Questions?

Planning Committee

Co-Chairs

Dave Ceryak Senior Director – Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company

Leslie T. Krasny Partner, Keller and Heckman LLP

Planning Committee

Aruni Bhatnagar, Professor of Medicine and Distinguished University Scholar, University of Louisville and American Heart Association
Carla Cartwright, Director, Global Regulatory Policy & Intelligence, Janssen Pharmaceuticals Inc.
Neil DiSpirito, Of Counsel, Ballard Spahr LLP
Joy Liu, Vice President, Commercial and Regulatory Legal, Vertex Pharmaceuticals
Jeff Nelligan, Communications for the Deputy Commissioner for Global Regulatory Operations and Policy, FDA
May Nelson, Deputy Director, Office of Regulations, Center for Tobacco Products, Office of Medical Products and Tobacco, FDA
Jeannie Perron, Partner, Covington & Burling, LLP
Kim Tyrrell-Knott, Member of the Firm, Epstein Becker & Green

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.

Call for Proposals

The Planning Committee thanks all who participated in the Call for Proposals that took place this past Fall. The broad input on topics from our members has helped us to put together a tremendous program.

Location and Overnight Accommodations

Conference Location

Ronald Reagan Building and International Trade Center  1300 Pennsylvania Avenue NW Washington, DC 20004

Overnight Accommodations

Rooms are available at a discounted rate of $309 a night through April 11, 2017 at the JW Marriott Hotel. After that date, rates and availability may vary. Make Reservation Business attire is recommended and some meeting rooms may have cooler temperatures. Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.